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1 jobs found in pennsylvania

Date: Feb 22, 2019
Location: Wayne, PA, US
Company: Teleflex
Expected Travel : Up to 50%
Requisition ID : 505
About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
Global Functions – The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
Position Summary
The Global Research and Data Specialist (GRADS) will support the Clinical and Regulatory activities which lead to and maintain regulatory compliance and approval for Teleflex Medical products globally. The GRADS is a member of the Global Research and Scientific Services Team.
Principal Responsibilities
· Prepare Clinical Evaluation Plans (CEP) and Post Market Clinical Follow Up (PMCF) plans for Teleflex devices.
· Implements and oversees PMCF activities
· Prepares the PMCF report and communicates the outcomes of PMCF activities to the relevant functions
· May be required to review author Clinical Evaluation Reports (CER), Post Market Surveys and other PMCF related documents.
· Review and assess published literature, pre-clinical data, clinical investigation results, field performance data and other relevant post-market surveillance data in order to evaluate device safety and performance
· Support the collaboration with KOLs and other clinical functions to strategize evidence generation including where to collect data, study design, evidence deliverables and dissemination (e.g. publication planning)
· Interface with key functional areas to obtain necessary information and documents required for the development and maintenance of PMCF activities
· Communicate the outputs of the PMCF process to ensure alignment with risk management documentation and instructions for use
· Collaborate with Global Regulatory Affairs and the Business Unit teams regarding PMCF activities
· Use technical/clinical writing skills to clearly describe technical information.
· Apply technical solutions to problem-solving.
· Understand standards and their application to medical devices (e.g. ISO 14155).
· Develop clinical evaluation best practices in line with relevant standards and guidelines.
· Ensuring that records are filed in accordance with procedures.
· Manage multiple projects simultaneously.
Education / Experience Requirements
· Baccalaureate or higher degree (Masters or Ph.D. preferred) in a clinical, scientific or engineering discipline
· Three years of experience working in a clinical/R&D/RA/QA medical device environment
· Experience in the development of clinical, scientific, and regulatory documents
· Excellent communication skills, both written and oral.
· Strong technical and scientific skills and the ability to effectively communicate these aspects in writing.
· Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases.
· Ability to understand and interpret results of published literature and clinical studies; basic working knowledge of statistics is required.
· Excellent interpersonal and team-oriented skills.
· Attention to detail and accuracy
· Fluent English, both written and oral
· Ability to work well under deadlines and pressure
· Problem-solving skills for developing creative solutions and meeting objectives
· Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
· Excellent analytical ability
· Ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
KEY RELATIONSHIPS/INTERFACES:
Clinical and Medical Affairs
Global QA/RA
Business Units
Research and Development
Operations
TRAVEL REQUIRED : Up to 50%